The FDA has accepted Alvotech (NASDAQ:ALVO) and Teva's (NYSE:TEVA) Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review ...
HORSHAM, Pa., Sept. 27 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ...
First Anti-TNF Infusion Therapy Approved in More Than a Decade for Patients Living with Moderately to Severely Active Rheumatoid Arthritis "Phase 3 data showed treatment with SIMPONI ARIA plus ...
On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at ...
If needed, Simponi Aria may be stored at room temperature up to 77⁰F (25⁰C) for a maximum single period of 30 days in the original carton to protect from light. Once Simponi Aria has been stored at ...
The European Commission has approved MSD’s biologic Simponi for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis. The European Commission has approved MSD’s ...
NEW YORK, April 13 (Reuters) - Johnson & Johnson and Schering-Plough Corp said on Monday that Canadian regulators had approved use of their experimental once-monthly drug Simponi to treat moderate to ...
One investigation seeks information from subsidiary, Janssen Biotech, which is located in Montgomery County. Johnson & Johnson disclosed this week in its quarterly earning report that the company and ...
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